MAUDE Adverse Event Report: DENTSPLY CAULK PALODENT V3 SYSTEM-RING REFILL-2 NARROW RINGS; INSTRUMENTS, DENTAL HAND

Catalog Number 659770V

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

While no serious injury resulted in this event, there has been a previous report received where this malfunction resulted in a serious injury.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

It was reported that a palodent v3 sectional matrix ring broke during use.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

• Brand Name: PALODENT V3 SYSTEM-RING REFILL-2 NARROW RINGS
• Type of Device: INSTRUMENTS, DENTAL HAND
• Manufacturer (Section D): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• MDR Report Key: 11029413
• MDR Text Key: 231798465
• Report Number: 2515379-2020-00014
• Device Sequence Number: 1
• Product Code: DZN
• Combination Product (y/n): N
• PMA/PMN Number: NA#S-P#NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 659770V
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 01/30/2021
• Supplement Dates FDA Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1